Based on discussions held during the meeting and prior written communications between Duska and the FDA, the company believes that the FDA would consider a new drug application (NDA) under section 505(b)(2) for ATPace subject to additional clinical data to be furnished by the company.
James Kuo, Duska’s Chairman and CEO, said: “Together with our CRO, Cato Research, we have already commenced activities aimed at the generation of the supplemental data requested by the FDA. The 505(b)(2) NDA filing provides an expedited route for potential approval of ATPace.”